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Synvisc-One® Safety Profile

Synvisc-One has a demonstrated safety profile in both initial and repeat treatments1

  • No serious side effects in target knee
  • Related local side effects were all mild to moderate (comprised of arthralgia, arthritis, arthropathy, injection site pain and joint effusion) and similar to saline control group
Patients with Device-Related* Adverse Events in the Injected Knee
  Synvisc-One

N=123

n (%)		 Saline Control

N=130

n (%)
Any Device-Related Adverse Event 7 (5.7%) 4 (3.1%)
*Defined as related to either the study injection or the study treatment

Study Detail

A randomized, double-blind, saline-controlled, multicenter trial of 253 patients (mean age 63 years) with moderate to severe OA knee pain. Most had radiographically confirmed Kellgren-Lawrence grade II or III OA at baseline. Patients initially received arthrocentesis and then either one 6-mL injection of Synvisc-One or one 6-mL injection of placebo (saline). Follow-up visits occurred at weeks 1, 4, 8, 12, 18, and 26.

The primary end point was the difference between the groups in the change from baseline in patient-assessed pain as measured by the WOMAC A score (average of 5 questions) over 26 weeks. A responder was defined as a patient with a ≥1 category improvement in WOMAC question A1 and no knee-related adverse events.

The safety of repeat treatment (week 26) with Synvisc-One was assessed in all patients over a 4-week period. Acetaminophen rescue was permitted up to 48 hours before study visits.

View the Complete Prescribing Information for Synvisc-One (PDF)

Indication

SYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non pharmacologic therapy and simple analgesics, e.g., acetaminophen.

Important Safety Information

SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee to be treated.

Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. Aspiration of any effusion prior to injection is highly recommended. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of SYNVISC and Synvisc-One have not been established in children or in pregnant or lactating women. It is unknown whether SYNVISC or Synvisc-One is excreted in human milk.

For SYNVISC
In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely.

View the Complete Prescribing Information for SYNVISC (PDF)

For Synvisc-One
The most commonly reported related local adverse events were transient, mild-to-moderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. No serious adverse events were reported in clinical trials in knees injected with Synvisc-One. Serious local adverse events have been reported only rarely in post-marketing use.  Repeat treatment did not affect the safety profile. In the pivotal clinical trial, there was one related systemic event of syncope. The most common systemic side effects irrespective of relationship to Synvisc-One were headache, back pain, nasopharyngitis and influenza. Systemic adverse event profiles were similar between patients in the Synvisc-One and Saline Control groups.

View the Complete Prescribing Information for Synvisc-One (PDF)

References

1. Synvisc-One Prescribing Information. Cambridge, MA: Genzyme Corp; 2009.